Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection

This study has been withdrawn prior to enrollment.
(Pharmaceutical company did not decide to renew contract.)
Sponsor:
Information provided by (Responsible Party):
Elizabeth Hecht, Columbia University
ClinicalTrials.gov Identifier:
NCT01094626
First received: March 25, 2010
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

The aim of our study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal papillary mucinous neoplasm (IPMN) lesions. Our hypothesis is that S-MRI is superior to MRI without secretin enhancement (N-MRI) in increasing tumor conspicuity, allowing for improved identification and more accurate measurement of lesions or precursor lesions in the pancreas.


Condition Intervention
Pancreatic Cancer
Intraductal Papillary Mucinous Neoplasm
Drug: Secretin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Difference in lesion conspicuity between S-MRI and N-MRI [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The primary outcome that we are interested in studying is whether S-MRI allows for better tumor detection secondary to anticipated increased conspicuity of tumor due to secretin's effect on increasing blood flow to the normal pancreas as compared to N-MRI. Determining S-MRI's efficacy versus that of N-MRI will be carried out by comparing tumor conspicuity measurements in S-MRI and N-MRI groups. Tumor conspicuity will be measured by calculating the contrast to noise ratio, placing region of interest (ROI) on tumor and adjacent tissue and dividing by image noise.


Secondary Outcome Measures:
  • Concordance of tumor measurements between S-MRI images and tumor specimens post-resection vs. concordance of tumor measurements between N-MRI and tumor specimens post-resection [ Time Frame: 45 days ] [ Designated as safety issue: No ]
    The secondary outcome will be the discrepancy in tumor size estimated from MRI and "confirmed" from post-surgical specimens. Tumor size estimated from MRI scans will be determined by measuring the greatest linear dimension (metric) of the lesion. Tumor size estimated by pathology will be directly measured using a linear scale (metric), taking the greatest linear dimension of the resected tumor. The discrepancy in estimated versus "confirmed" tumor size will be compared between S-MRI and N-MRI groups.


Enrollment: 0
Study Start Date: April 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secretin
Single arm (randomized).
Drug: Secretin
A minimum of 15 patients, maximum of 30 patients, will each undergo an S-MRI evaluation, at a dose of 0.2 ucg/kg per exam. Secretin provided by the Repligen Corporation, will be administered by IV bolus injection over 1 minute followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Other Name: RG1068

Detailed Description:

Pancreatic cancer remains the fourth leading cause of cancer-related death in the United States and is marked by advanced stage at diagnosis and a high mortality rate. Intraductal papillary mucinous neoplasm, IPMN, is a cystic lesion that can be potentially cancerous, leading to pancreatic adenocarcinoma. Currently, there is no existing imaging modality that is both sensitive and cost-effective enough in accurately measuring or detecting adenocarcinoma and IPMN. Improving the methods used in identification and localization of this disease is critical.

Secretin, a hormone produced by duodenal mucosal cells increases blood-flow to the pancreas. Our hypothesis is that as secretin increases blood flow to the pancreas, there will be increased conspicuity in areas of dysplasia/cancer where there is minimal blood-flow, enhancing tumor detection. The investigators are conducting a prospective, randomized-control pilot study of thirty patients with IPMN or pancreatic cancer who are undergoing surgical resection at Columbia University's Pancreas Center. Fifteen patients will be randomly selected to undergo S-MRI prior to surgery and fifteen patients will be selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex, race and tumor-type. The investigators will first evaluate if secretin allows for increased tumor conspicuity, enhanced visualization of the lesion, by comparing the calculated tumor conspicuity of S-MRI to N-MRI groups.

The investigators will then assess if S-MRI imaging allows for increased accuracy in lesion measurements by looking at the concordance in measurements between S-MRI and tumor specimens post-resection as compared to the concordance in measurements between N-MRI and tumor specimens post-resection.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Histologically confirmed IPMN/pancreatic adenocarcinoma by biopsy or fine needle or suspected IPMN/pancreatic adenocarcinoma based on imaging
  • Scheduled for surgical resection
  • Willingness to provide informed consent.

Exclusion Criteria:

  • Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator or cochlear implants)
  • Unresectable tumor
  • Other abdominal neoplasm in addition to neoplasm in pancreas
  • Contraindication to surgery, including but not limited to recent MI (within 6 weeks) or poor pulmonary function
  • History of sensitivity to secretin
  • Pregnancy
  • Estimated GFR < 30 mL/min/1.73 m2 (as per MDRD Study equation)
  • Unwillingness or inability to provide informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01094626

Sponsors and Collaborators
Elizabeth Hecht
Investigators
Principal Investigator: Elizabeth Hecht, MD Columbia University
  More Information

No publications provided

Responsible Party: Elizabeth Hecht, Associate Professor of Clinical Radiology, Columbia University
ClinicalTrials.gov Identifier: NCT01094626     History of Changes
Other Study ID Numbers: AAAE5847
Study First Received: March 25, 2010
Last Updated: January 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Pancreatic adenocarcinoma
Intraductal papillary mucinous neoplasm
Imaging techniques
Pancreatic surgical resection
Synthetic human secretin

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014